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Boston Scientific Begins Clinical Trial for Pacing Leads

April 23, 2014 9:24 am | by Boston Scientific | News | Comments

Boston Scientific Corporation has conducted the first implant in the clinical trial of the next generation ACUITY X4 left-ventricular (LV) pacing leads and RELIANCE 4-FRONT defibrillation (ICD) leads. The clinical trial is designed to establish...

First U.S. Implant of ICD System that Allows Full-Body MRI Scans

April 22, 2014 10:22 am | by Medtronic | News | Comments

Medtronic has announced the first U.S. implant of the Evera MRI SureScan implantable...

Federal Appeals Court Agrees to Medtronic Request to Postpone Injunction

April 22, 2014 9:18 am | by Medtronic | News | Comments

The Federal Circuit Court of Appeals today granted a request from Medtronic, Inc. to postpone...

Plates Give Surgeon Customized Design

April 21, 2014 10:53 am | by DePuy Synthes CMF | News | Comments

DePuy Synthes CMF (Craniomaxillofacial), a leader in skeletal and soft tissue repair and...

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MGS Purchases Hospira Molding Facility

April 21, 2014 10:27 am | by MGS Mfg. Group | News | Comments

MGS Mfg. Group, headquartered in Germantown, Wisconsin, announced it has purchased Hospira’s Buffalo, New York injection molding facility. The formal declaration was made to facility employees on Monday, April 14, 2014 by members of Hospira...

Endurant AAA Stent Graft Continues Exceptional Long-Term Performance

April 21, 2014 10:18 am | by Medtronic Inc. | News | Comments

The Endurant AAA stent graft system from Medtronic, Inc. continues to demonstrate exceptional long-term performance in the endovascular treatment of abdominal aortic aneurysms, according to new clinical data presented for the first time...

Court Agrees to an Expedited Appeal in CoreValve System

April 21, 2014 9:13 am | by Medtronic Inc. | News | Comments

Medtronic, Inc. today issued an updated statement on the recent ruling by Federal District Court of Delaware. The ruling granted in part Edwards Lifesciences' motion for a preliminary injunction that prevents Medtronic from selling or offering...

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Heart Device Lawsuits Continue Against St. Jude Over Defective Riata Lead Wires

April 18, 2014 2:38 pm | by The Associated Press | News | Comments

The Torkzadeh Law Firm (TorkLaw) is now representing over 100 clients against St. Jude Medical, Inc. related to the recalled St. Jude Medical, Inc. Riata leads. In November 2011, the FDA issued a Class 1 recall of the St. Jude Medical Riata...

FDA Approval for New Defibrillators and Heart Failure Devices

April 16, 2014 10:17 am | by Boston Scientific | News | Comments

Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. The newly approved devices include the DYNAGEN MINI and INOGEN MINI ICDs, as well as...

Preliminary Injunction Against Guidezilla Catheter Vacated by Federal Circuit

April 16, 2014 10:09 am | by Vascular Solutions | News | Comments

Vascular Solutions, Inc. announced that a three judge panel of the U.S. Court of Appeals for the Federal Circuit today vacated the preliminary injunction that was previously issued by the District Court for the District of Minnesota effective...

Imaging’s Role in Cancer Research

April 14, 2014 2:08 pm | by Gregory Sorensen, MD, President and CEO, Siemens Healthcare North America | Blogs | Comments

Anyone who hears the words, “You have cancer,” wants to hear next that they will survive.  Thankfully today, more patients are indeed beating the disease.  Medical imaging is an integral part of many survivors’ personal victories over the disease...

Abbott Receives 510(k) for Test to Help Diagnose Diabetes

April 14, 2014 11:31 am | by Abbott | News | Comments

Abbott announced today that its new ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test - which can aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease - has received 510(k) clearance...

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Covidien Gets FDA 510(k) Clearance for Kangaroo Feeding Tube with IRIS Technology

April 14, 2014 11:20 am | by Covidien | News | Comments

Covidien today announced U.S. Food and Drug Administration 510(k) Clearance for the Kangaroo feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing...

Medtronic to Appeal Federal District Court Ruling

April 14, 2014 11:07 am | by Medtronic Inc. | News | Comments

The Federal District Court of Delaware today granted in part Edwards Lifesciences' motion for a preliminary injunction that prevents Medtronic, Inc. from selling or offering to sell its CoreValve System in the United States. Today's ruling has...

Opportunities and Challenges of Doing Business in Companion Diagnostics

April 14, 2014 9:56 am | by Richard Park, Contributing Editor | Blogs | Comments

For my occasional series of blogs examining various facets of the companion diagnostics market, I asked some of the major IVD manufacturers to share their thoughts and opinions on the current opportunities and challenges in companion...  

Covidien Implements Voluntary Recall of its Pipeline Embolization Device and Alligator Retrieval Device

April 11, 2014 10:14 am | by Covidien | News | Comments

Covidien plc has announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied...

First Patient Enrolled in Clinical Registry Assessing Boston Scientific Vercise Deep Brain Stimulation System in Patients with Parkinson's Disease

April 11, 2014 10:07 am | by PR Newswire | News | Comments

Boston Scientific Corporation has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise™ Deep Brain Stimulation (DBS) System in patients with Parkinson's disease. DBS is a surgical...

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First Patient in U.S. to Receive MRI Scan in Clinical Study of MRI-Compatible Pacemaker

April 10, 2014 8:36 pm | by PR Newswire | News | Comments

Providence Saint Joseph Medical Center is the first hospital in the nation to conduct an MRI scan of a patient implanted with a new MRI-compatible pacemaker – a breakthrough because metal implants often exclude patients from this imaging...

Medtronic CRT Devices Now Approved to Treat Patients with AV Block and Reduced Heart Function

April 10, 2014 7:33 pm | by The Associated Press | News | Comments

Medtronic, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for biventricular (BiV) pacing with Medtronic cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D)...

Philips Handheld Blood Test Shows Further Promise in Clinical Setting

April 10, 2014 10:37 am | by Philips Electronics | News | Comments

Royal Philips has completed its first field study for its Minicare handheld cardiac Troponin-I (cTn-I) blood test, demonstrating the platform’s potential to produce lab-equivalent results with finger prick samples within minutes. The...

Abbott Completes Enrollment of AbsorbT Randomized Clinical Trials in the U.S., Japan, and China

April 10, 2014 8:31 am | by The Associated Press | News | Comments

Abbott has announced it has completed enrollment of three clinical trials to support approvals of the company's revolutionary AbsorbT Bioresorbable Vascular Scaffold (BVS) in the United States, Japan and China. Combined, the U.S., Japan and...

St. Jude Medical Recognized as Innovative Technology Supplier of the Year

April 9, 2014 12:19 pm | by St. Jude Medical Inc. | News | Comments

St. Jude Medical, Inc., a global medical device company, was recognized by Novation as the 2013 Innovative Technology Supplier of the Year. Novation members selected the St Jude Medical ILUMIEN PCI Optimization System based on their experience...

New Anspach High Speed Drill System Debuts at AANS Annual Meeting

April 9, 2014 10:46 am | by DePuy Synthes Power Tools | News | Comments

DePuy Synthes Power Tools* announced the global launch of the Anspach EG1 High Speed Electric System, a next generation high-speed electric drill with multiple attachments and accessories, designed for use in neurosurgery, otology and spinal...

Cardiac Device Keeps Heart Going

April 8, 2014 3:15 pm | by Jennifer R. Lloyd, San Antonio Express-News | News | Comments

With a weak heart muscle and heart valve problems, Ruben Rivera said he was apprehensive about having a new type of battery-powered defibrillator implanted under his skin that could shock his heart if it sensed an irregular rhythm. But the...

GE Healthcare Receives FDA Clearance For Q.Clear Technology

April 8, 2014 9:34 am | by PR Newswire | News | Comments

GE Healthcare, a unit of General Electric Company, has announced that it received U.S. FDA 510(k) clearance of its Q.Clear technology – technology that can provide up to two times improvement in both quantitative accuracy and image quality...

Boston Scientific's Endoscopic Ultrasound Needle Is for Use During Fine Needle Aspiration Procedures

April 7, 2014 6:31 pm | by PR Newswire | News | Comments

Boston Scientific Corporation has received clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which is now globally available for Endoscopic Ultrasound-Fine Needle...

'IN.PACT Admiral' Drug-Coated Balloon from Medtronic Outperforms Standard Angioplasty

April 7, 2014 10:34 am | by Medtronic Inc. | News | Comments

Patients with peripheral artery disease in the upper leg experienced significantly better outcomes at 12 months after treatment with the IN.PACT Admiral drug-coated balloon from Medtronic, Inc. than with standard balloon angioplasty, according to a landmark...

Installation of World's First High-Field MRI-Guided Radiation Therapy System

April 7, 2014 10:27 am | by Elekta | News | Comments

Elekta, Royal Philips and University Medical Center (UMC) Utrecht (the Netherlands) announced today that the initial components of the world's first high-field magnetic resonance imaging (MRI) guided radiation therapy system are being installed...

Transvaginal Mesh Patient Awarded $1.2 Million in Ethicon Mesh Lawsuit, Announces Baron and Budd

April 4, 2014 11:44 am | by The Associated Press | News | Comments

A Dallas jury found transvaginal mesh manufacturer Ethicon and its parent company Johnson & Johnson liable for defects associated with the company’s TVT-O transvaginal mesh sling. The mesh patient, Linda Batiste, was awarded $1.2 million...

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